Phase 1-2 of Temozolomide and Hypofractionated Radiotherapy in Tx of Supratentorial Glioblastoma Multiform

Completed · Phase 1/Phase 2

Conditions studied: Glioblastoma, Cancer of Brain and Nervous System, Glioblastoma Multiforme

In brief

The purpose of this study is to investigate the safety and effectiveness of a combination treatment for glioblastoma multiforme utilizing radiotherapy plus the FDA-approved chemotherapy drug temozolomide

Key facts

Study ID

NCT01120639

Run by

Stanford University

People needed

30

Starts

2010-04-01

Expected to finish

2020-11-15

Last updated by the study team

2021-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histopathologically confirmed newly diagnosed glioblastoma multiforme. Diagnosis must be made by surgical biopsy or excision
• The tumor must be supratentorial in location
• The planning target volume (tumor plus margin) must measure ≤ 150 cm\^3 in volume
• Age ≥ 18 years
• Life expectancy of at least 12 weeks
• Patient must have adequate organ function to tolerate temozolomide (details in the protocol)

You may not qualify if…

• Patients who have previously been treated with brain irradiation to the region that would result in overlap of the radiation fields
• Tumor foci detected below the tentorium
• Multifocal disease or leptomeningeal spread
• Prior allergic reaction to the study drugs involved in this protocol
• Patients with pacemaker will be allowed to undergo CT instead of MRI
• Pediatric patients (age < 18), pregnant women, and nursing patients will be excluded

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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